Title:Efficacy and Safety of Pembrolizumab Monotherapy or Combined Therapy in Patients with Metastatic Triple-negative Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Volume: 25
Issue: 1
Author(s): Mahmood Araghi, Farshad Gharebakhshi, Fatemeh Faramarzi, Alireza Mafi, Tahoora Mousavi, Mina Alimohammadi*Hussein Soleimantabar*
Affiliation:
- Student Research
Committee, Department of Immunology, School of Medicine, Shahid Beheshti University of Medical Sciences,
Tehran, Iran
- Department of
Radiology, School of Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran,
Iran
Keywords:
Pembrolizumab, mTNBC, efficacy, safety, monotherapy, combined therapy, meta-analysis.
Abstract:
Background: Metastatic Triple-negative Breast Cancer (mTNBC) is the most aggressive
form of breast cancer, with a greater risk of metastasis and recurrence. Research studies have
published in-depth analyses of the advantages and disadvantages of pembrolizumab, and early data
from numerous trials suggests that patients with mTNBC have had remarkable outcomes. This
meta-analysis compares the data from numerous relevant studies in order to evaluate the safety
and efficacy of pembrolizumab monotherapy or combination therapies for mTNBC.
Methods: To identify eligible RCTs, a thorough literature search was carried out using electronic
databases. CMA software was utilized to perform heterogeneity tests using fixed and random-effects
models.
Results: According to our pooled data, the median Progression-free Survival (PFS) was 2.66
months, and the median overall survival (OS) was 12.26 months. Furthermore, by comparing efficacy
indicators between PD-L1–positive and PD-L1–negative groups, a correlation was found between
the overexpression of PD-L1 with OS, PFS, and ORR. Patients with PD-L1-positive tumors
had a higher response rate, with an ORR of 21.1%, compared to the patients with PD-L1-negative
tumors. The ORR for first-line immunotherapy was higher than that of ≥second-line immunotherapy.
In addition, pembrolizumab plus combination treatment resulted in a pooled incidence of immune-
related adverse events of 22.7%.
Conclusion: A modest response to pembrolizumab monotherapy was detected in the mTNBC patients.
Furthermore, a better outcome from pembrolizumab treatment may be predicted by PD-L1--
positive status, non-liver/lung metastases, combination therapy, and first-line immunotherapy.
Pembrolizumab, in combination with chemotherapy, may be more beneficial for patients whose tumors
are PD-L1 positive.
